UTEK’S CUSTOMERS

Neustadt am Rübenberge

Solvay Pharmaceuticals

2002-2004, 2005-2007, 2008-2012, since 2014

Planning, Compliance Engineering, Qualification

• Preparation of CE marking for newly constructed subplants (pelletizing, drying), in particular the preparation of operating instructions and the performance of risk assessments
• Preparation and updating of explosion protection documents according to § 6 of the Ordinance on Hazardous Substances for partial plants in a production building
• Re-qualification of packaging lines in a packaging plant in pharmaceutical production
• Operational support of an active ingredient plant (including planning and execution of maintenance and repair work, preparation of a BImSchG application)
• Conceptual design and basic engineering for a renewal of the supply and exhaust air system of a ball coater and various solids handling systems
• Preparation of a feasibility study for a new active substance plant
• Preparation of explosion protection documents for the entire production site, engineering activities within the scope of various projects
• Qualification of water and compressed air supply systems for pharmaceutical production facilities
• Qualification of ventilation and air conditioning systems for a pharmaceutical production facility and its storage areas

Langenfeld

Aker Kvaerner, Acquisition by Jacobs 2011

2005-2009

Planning, Compliance Engineering

• Project management for the modification of a gas processing plant and the process monitoring for the replacement or retrofitting of pumps according to TA Luft at the Hamburg site of Shell Deutschland Oil GmbH
• Process design for the modification of pumps and pipelines to meet the requirements of TA Luft at the Hamburg and Heide sites of Shell Deutschland Oil GmbH
  Process Design for the modification of a crude oil distillation plant for the processing of crude oils with high acid number
• Concept development and basic process design for the redesign of filter systems in coke gas and pilot gas networks at the Scholven and Horst sites of BP Gelsenkirchen GmbH
• Safety assessments for flare network systems of petrochemical plants, process engineering assessment of the plants for different load cases/hazard scenarios using process simulation software (HYSYS, Flarenet)
• Preparation, execution and follow-up of HAZOP studies in the context of updating safety reports using the Lihou software for BP Gelsenkirchen at the Horst site

Leverkusen

LANXESS

since 2019

Compliance Engineering

• Review and optimization of a plant documentation concept for Therban operation with special consideration of compliance requirements (e.g. inspection obligations according to AwSV and BetrSichV)
• Completion and supplementation of the existing plant documentation on the basis of the developed concept
• Preparation of AwSV plant documentation in accordance with § 43 AwSV, taking into account the requirements of TRwS 779 for Therban operation

Wuppertal

DuPont Performance Coatings, DuPont Herberts, Herberts

1998-1999, since 2000

Planning, Compliance Engineering

• Processing of approval documents (modification approvals incl. preparation of plant-related safety reports and execution of environmental impact assessments, notifications of modifications and objections according to BImSchG, permits according to VbF, suitability determinations according to Wasserhaushaltsgesetz (WHG) in a plant for the production of coatings and a plant for the production of synthetic resins, e.g. for production facilities, storage facilities, tanking stations and a container cleaning plant
• Front End Loading and SHE – support of projects (preparation of project descriptions, SHE reviews, preparation of project approval meetings, comparison of European and American regulations)
• Performance of Process Hazards Analyses using the What-if method for chemical and physical processes (tank farms, storage and handling areas, paint booths, etc.)
• Preparation of explosion protection documents according to § 6 of the Ordinance on Industrial Safety and Health (BetrSichV) for various plants (storage facilities for highly flammable liquids, paint booths, etc.)
• Preparation and supervision of recurring expert inspections for HBV plants according to WHG (preparation of plant documentation, on-site surveys and updating of flow diagrams, coordination of inspection dates)
• Preparation and implementation of a concept for the consideration of water law requirements for so-called staging areas for the Wuppertal 2 site
• Preparation of a concept for the preparation of permit statuses and implementation of the concept for both Wuppertal sites
• Process engineering and engineering design of subplants for the production of coatings and synthetic resins

Bergkamen

Bayer Schering Pharma

1997-2002, 2007, since 2009

Planning, Compliance Engineering, Qualification

• Execution of criticality analyses for preventive maintenance planning as well as preparation of spare parts lists for power plants and other infrastructure facilities
• Development of spare parts concepts for solids processing plants and rectification columns
• Reconciliation, revision, supplementation and restructuring of the documentation of functional locations, equipment and inventories in SAP for power plants and other infrastructure facilities as well as plant fire brigades
• Detail engineering for several rectification columns and related peripheral equipment
• Planning, organization and follow-up of the execution of safety-related measures
• Basic and detail engineering as well as preparation of requirement and functional specifications for various new and rebuild projects in power plants and infrastructure facilities
• Preparation of work instructions, execution of risk assessments according to §3 BetrSichV and §7 GefStoffV, preparation and revision of explosion protection documents and explosion protection concepts
• Preparation of plant documentation according to §3 Para. 4 VAwS and §43 AwSV for various production and infrastructural HBV plants (e.g., feeders, stirred reactors, fermenters, columns, evaporators, centrifuges, dryers, scrubbers, wastewater and exhaust gas treatment) as well as storage and filling plants (e. g., tank farms, container farms, storage containers, active storage and filling and emptying points).
• Preparation of plant documentation in accordance with §43 AwSV for self-consumption filling stations in accordance with TRwS 781
• Preparation of operational plant registers, updating and new preparation of internal plant guidelines and checklists, preparation and coordination of inspections under water law by the ZÜS and for obtaining §7 Para. 4 certificates in accordance with VAwS NRW, coordination of the preparation of stability certificates and test statics with regard to the requirements of the AwSV and in accordance with TRAS 320
• Carrying out a risk assessment of cleaning processes with regard to cross-contamination in microbiological operations
• Coordination of the preparation of initial status reports for the plant-wide IED facilities (production plants as well as infrastructural plants) as well as support in the preparation of application documents within the scope of immission control approval procedures
• Support of various plants and the Health, Safety and Environment (HSE) department in the area of communication with authorities (AZ) in the preparation and processing of BImSchG applications
• Carrying out safety assessments (hazard analyses) for process plants (HAZOP, PAAG, FMEA, AEA) for various production and utility companies
• Maintenance planning for a power plant
• Preparation of risk potential studies for the calculation of the adiabatic temperature increase of various active ingredient syntheses
• Preparation of a study for the optimization of an evaporator plant for solvent reprocessing; preparation of operating manuals for process engineering subplants
• Creation of operational maintenance plans for GMP-compliant maintenance planning with SAP R/3 PM module for technical site supply
  Process engineering design of a partial vacuum condensation for a fermenter in microbiology
• Project-accompanying engineering services (preparation of RI flow diagrams, preparation of operating and process descriptions, acceptance tests according to pressure vessel regulations)
• Plant qualification of active ingredient and fermenter plants, processing of operating documentation
• Process simulation of an absorber plant in the central apparatus exhaust air system, determination of the required cooling capacity
• Process engineering design of the primary heating and cooling circuit (ethylene glycol-water) of an active ingredient plant
• Creation of equipment subject to inspection and operational maintenance plans in the SAP R/3 PM module
• Creation of training documents in the area of maintenance planning, creation of master plans for maintenance planning

Dormagen

since 2019

Compliance Engineering

• Screening of a pesticide active ingredient plant’s safety considerations (A-tests) for safety-related safeguards for updating that plant’s general permit
• Assisting in the transfer of a new process’s safety consideration into the format for a pesticide active ingredient plant’s permit application

Leverkusen

2015-2019, since 2020

Qualification, Compliance Engineering

• Project-accompanying and consulting engineering services for the implementation of systematic hazard analyses according to the PAAG/HAZOP process in compliance with Bayer regulations for a solid waste plant (review and evaluation of existing plant documentation, compilation of process-related substance data, determination of further necessary basic data, comparison and adaptation of the documentation with the plant inventory on site, preparation of documents for the PAAG meetings with incorporation of the generated basic data)

Monheim

since 2015

Compliance Engineering

• Carrying out systematic hazard analyses using the PAAG/HAZOP method in accordance with Bayer regulations for various infrastructure systems (e.g. process water, drinking water and deionized water systems) of laboratory buildings (existing buildings, new construction projects)
• Preparation of a plant documentation according to § 43 AwSV for a planned self-consumption filling station using TRwS 781
• Performance of hazard field analyses for various ventilation and air conditioning systems in laboratory areas and a shipping warehouse
• Performance of quality-relevant risk assessments of existing VE water pipeline networks (determination of basic technical data, definition of assessment factors, on-site inspection of the pipelines and recommendation of measures)
• Elaboration of work instructions for the monitoring of VE water and drinking water networks on the basis of the Drinking Water Ordinance, the associated guidelines and on the basis of specific customer requirements
• Elaboration of a technical concept for filtration optimization on an existing filter cascade for demineralized water
• Preparation of a technical specification for the procurement of mobile deionized water plants, preparation of technical evaluations and participation in the awarding of contracts
• Preparation, execution and moderation of risk assessments according to § 3 BetrSichV and § 7 GefStoffV for a storage lift and fire protection rack container in cooperation with the plant management and the plant engineering department
• Revision and extension of the explosion protection document for a warehouse operation

Wuppertal Elberfeld

BTS (Bayer Technology Services)

2005-2009, since 2012

Planning, Compliance Engineering, Qualification

• Creation of a concept for restructuring and transferring the auxiliary and operating material lists at the site into SAP
• Project-accompanying and coordinating engineering services for conversion measures to increase the capacity of an ultrafiltration plant for the concentration of an oral antidiabetic produced by fermentation (preparation and revision of P&I flow diagrams, design of equipment, development of an adapted CIP process, revision and optimization of process descriptions, preparation and maintenance of project-related documentation, cost estimation, coordination of and exchange with service providers involved in the project).
• Conceptual design for the installation of various apparatus in an explosion-proof clean room
• Elaboration and writing of operating instructions according to § 44 AwSV for various plants based on the AwSV plant documentation
• Restructuring, revision and digitalization of archives with S+I plans, drawings, plant documentation by working students
• Approval planning for suitability determination procedure according to § 63 WHG and notification procedure according to § 40 AwSV for various LAU and HBV plants
• Basic and detail engineering, project management incl. supervision of installation of various conversion projects in GMP and non-GMP environment (refrigeration plant, RLT plant, boiler energy control …)
• Re-evaluation and preparation of AwSV plant documentation for various laboratory buildings, taking into account the requirements of AwSV and DWA-A 779
• Preparation of VAwS plant documentation for LAU and HBV plants taking into account the requirements of VAwS and DWA-A 779
• Pre basic engineering, basic engineering, detail engineering and qualification of various process and infrastructure plants within the CEB project
• Project-accompanying and coordinating engineering services within the scope of a clinic sample project for ADC filling
• Project-accompanying and coordinating engineering services for the qualification of pharmaceutical plants, preparation and execution of DQ, IQ and OQ documents
• Basic and detail engineering incl. coordination, commissioning and start-up of various package units and subplants for the construction of a new laboratory and pilot plant building in a GMP-regulated environment.
• Project-accompanying basic and detail engineering in the context of the cell culture fermenter new building
• Project-accompanying engineering services (preparation of RI flow diagrams for various subplants, design of the main equipment for a new fermentation plant, conversion of a production line in an active ingredient plant to Hastelloy material)
• Project-related engineering services (preparation of RI flow diagrams for the supply systems, design of the main equipment for a new fermentation plant)

Ingelheim

2002-2007

Qualification of pharmaceutical plants

• Qualification of various systems and mobile equipment in active pharmaceutical ingredient production; preparation of user requirements, risk analyses, functional descriptions, IQ and OQ plans, as well as performance of tests and preparation of reports
• Qualification of ventilation systems for active pharmaceutical ingredient production
• Qualification of ventilation systems for the production of active pharmaceutical ingredients
• Restructuring of the technical documentation and qualification of a central tank farm for the production of active pharmaceutical ingredients

Marburg

ZLB Behring, Aventis Behring, Centeon

since 1999

Planning, Qualification

• Process and control qualification of pharmaceutical equipment (e.g. freeze dryers, steam sterilizers) and systems (e.g. particle monitoring system, chart recorder system, various automation systems and image processing systems). Automation systems and image processing systems), mobile equipment (e.g. laboratory equipment such as chromatography systems, transfer carts B-range), supply media (e.g. HVAC, PUW, WFI, AIP), clean and temperature controlled rooms (classified rooms D, C and B, as well as e.g. cold rooms, tempering cabins, incubators) within the scope of routine changes and new installations for the production of pharmaceutical drugs in the area of research, manufacturing, filling, post inspection area and final packaging.
• General activities qualification:Reviews of specifications, functional specifications, FATs and SATs from external suppliers, as well as preparation, execution and review of internal SATs, studies (e.g. smoke studies, statistical filling volume studies filling, temperature distribution studies), risk analyses or qualification plans (IQ, OQ and PQ). Preparation and review of regulatory reports such as certificates and test summaries.
• Qualification measurements and validation such as temperature distribution measurements of freeze dryers, steam sterilizers and temperature controlled rooms. Cleaning validation (e.g. spray shadow test) of e. g. equipment dishwashers and hose dishwashers.
• Qualification of pharmaceutical plants for the reengineering of a blood plasma fractionation plant ( e.g. water bath, thawing plant, thawing container, process container incl. periphery, rinsing machines, wash ware carriers, solids addition).
  Basic engineering within a project for new project planning of a blood plasma fractionation system for e.g. thawing, defrosting, shredding, and paste filtration systems, spare parts management (preparation of spare parts list, request and review of quotations).
• Preparation of various documents such as requirement specifications, specifications, test studies, AIM lists, RV lists
• Basic engineering for the acquisition of two liquid filling lines (during/in productive operation of the filling area), each with bottle rinsing machine, hot air sterilization tunnel, filling machine and crimping machine incl. qualification
• Qualification of new ventilation systems with installation of new personnel airlocks (during/in productive operation of the filling area). Implementation of pressure level concept for airlocks and production area of the overall filling area during a “shut down” phase.
• Basic engineering for a pilot project for the standardization of formats on packaging lines incl. qualification (preparation of risk analyses, functional descriptions, IQ and OQ plans as well as execution of tests and preparation of reports) Qualification of pharmaceutical plants for the reengineering of a blood plasma fractionation plant ( e.g. water bath, thawing plant, thawing container, process container incl. periphery, rinsing machines, wash ware carriers, solids addition).
• Basic engineering within a project for new project planning of a blood plasma fractionation system for e.g. thawing, defrosting, shredding, and paste filtration systems, spare parts management (preparation of spare parts list, request and review of quotations).
• Preparation of various documents such as requirement specifications, specifications, test studies, AIM lists, RV lists
• Basic engineering for the acquisition of two liquid filling lines (during/in productive operation of the filling area), each with bottle rinsing machine, hot air sterilization tunnel, filling machine and crimping machine incl. qualification
• Qualification of new ventilation systems with installation of new personnel airlocks (during/in productive operation of the filling area). Implementation of pressure level concept for airlocks and production area of the overall filling area during a “shut down” phase.
• Basic engineering for a pilot project for the standardization of formats on packaging lines incl. qualification (preparation of risk analyses, functional descriptions, IQ and OQ plans as well as execution of tests and preparation of reports)
• Project supervision and qualification of plants and equipment for the production, purification and packaging of recombinant plasma proteins (rFVIII) for clinical studies
• Preparation of a feasibility study of a clean room conversion to optimize the product flow incl. cost estimation and scheduling
• Basic engineering for the conversion of a virus filtration in a production plant (preparation of the process flow diagram, scheduling)
• Qualification of various plants and mobile equipment within the scope of the conversion of a production area for the manufacture of recombinant proteins; preparation of risk analyses, functional descriptions, IQ and OQ plans as well as performance of the tests and preparation of the reports
• Elaboration of a site master plan for a finishing plant (determination of production, logistics, building and infrastructure requirements based on future volume forecasts, actual/target analysis of production and logistics capacities)
• Elaboration of qualification plans for various laboratory equipment, execution and documentation of qualification tests
• Preparation of a concept for a neutralization plant, preparation of a risk analysis, elaboration of the inquiry specifications
• Engineering activities within a scale-up project in blood fractionation
• Qualification of a finishing plant, preparation of the validation master plan according to SOP, management of the external qualification team
• Documentation and engineering activities for an ethanol storage and condensate system
• Engineering activities in laboratory plant qualification

Essen

Evonik Goldschmidt

2011-2013, since 2016

Planning, Compliance Engineering

• Revision and preparation of explosion protection documents in accordance with § 6 GefStoffV for various production plants, preparation of explosion protection concepts taking into account TRGS 720-722 and classification of PLT protective devices in accordance with TRGS 725 for the various subplants of these plants
• Preparation, execution and moderation of hazard assessments according to § 3 BetrSichV in cooperation with the plant management and the plant engineering department
• Processing of the actions of the systematic hazard analyses (PAAG) for a chemical production and supervision of the project-technical implementation of the PAAG actions
• Process engineering optimization of an exhaust air system of a chemical production plant
• Pre-basic engineering for a new production plant (preparation of block and process flow diagrams, determination of batch sizes and batch times on the basis of OEE key figures, elaboration of chronograms, determination of geometric data of the main equipment, layout planning)
• Basic engineering for the change of the conveying medium of the pneumatic conveyors in the superabsorber production (elaboration of an explosion protection concept, cost estimation and profitability calculations for the planned measures, support of the project management)
• Pre-Basic and Basic Engineering for a new subplant in chemical production (preparation of block, process and RI flow diagrams, preparation of plant descriptions, execution of process engineering calculations, preparation of technical specifications and equipment lists, installation planning, support of the technical department in the permit application, support of the project management, assistance in the preparation of the logistics concept)

Hannover

2016-2017

Compliance Engineering

• Preparation and drafting of BImSchG approval documents for the construction of a gas-fired combined heat and power plant within a planning approval procedure under mining law for the expansion of an oil field in Emsland (including plant description, AwSV-/VAwS concept, plant safety concept)

Oelde

2007-2009, 2012-2013

Planning

• Process engineering planning, design and execution of international separator and decanter projects in the business line chemicals, pharmaceuticals, biotechnology, minerals
• Coordination of technical problems, monitoring of production schedules as well as support of end customers and subsidiaries
• Preparation of layout plans, process flow diagrams and technical documentation